Abstract

Background

Voluntary participation of a subject in research respects a subject's rights, strengthens
its ethical conduct, and is formalized by the informed consent process. Clinical trials
of life-saving interventions for medical emergencies often necessitate enrolment of
patients where prior written individual informed consent is impossible. Although there
are regulations and guidelines on protecting subjects in emergency research, these
have been criticised for being limited and unnecessarily restrictive. Across Europe
and the United States stringent regulations have resulted in a substantial decline
of clinical trials involving emergency interventions.

Methods

We are conducting a trial of fluid resuscitation in children with hypovolaemic shock
in six hospitals across three malaria-endemic African countries. The design is pragmatic
as children are enrolled on clinical criteria alone and is being conducted in hospitals
with facilities typical of many district hospitals across Africa. The trial aims to
inform strategy for managing children with febrile illness and features of shock.
In order to develop appropriate consent processes for the trial, we conducted a narrative
review of current international recommendations for emergency consent.

Results

Practical or specific guidance was generally sparse or confusing with few examples
in the literature to direct our informed consent process. For a sub-group of children
who were critically sick or where parents themselves were otherwise too distressed
to consider prior written consent, we opted for a modified form of deferred consent.
This included verbal assent from guardians at the point of enrolment, with full written
consent obtained after stabilising the child. For children who died prior to full
written consent, ethical permission was received to waiver full consent.

Conclusions

In light of the controversy around guidance and regulations in this area we report
how and why we have used a modified system of deferred consent in an emergency intervention
trial in children. Although approved by all relevant ethics committees and operational
in 3 countries in Africa, formal research is now necessary to explore the perceptions
and experiences of parents, health workers, researchers and ethics committees of the
modified method of deferred consent.